< Back

Galapagos successfully completes Phase I clinical trials for rheumatoid arthritis candidate drug GLPG0259

23 February 2010 at 07:30 CET

Mechelen, Belgium; 23 February 2010 - Galapagos NV (Euronext: GLPG) announced today that it has completed Phase I clinical trials for GLPG0259, a novel mechanism-of-action candidate drug being developed for rheumatoid arthritis (RA).  These results support the design of a Phase II study planned to start later this year, where the efficacy of the novel candidate drug will be assessed in RA patients.  Galapagos will present detailed results of GLPG0259 and other programs during an R&D Update scheduled for 19 March 2010.

The Phase I studies for GLPG0259 have shown a good safety profile in healthy volunteers and confirm a once-daily oral dosing regimen.  Furthermore, the studies have confirmed the feasibility of combining GLPG0259 with methotrexate (the current standard treatment for RA) in future trials.  A similar safety and PK profile was observed for the capsule formulation of GLPG0259, which will be used in the Phase II efficacy trial in RA patients scheduled to begin in the third quarter of 2010.

"This latest clinical study further demonstrated the safety and once-daily dosing of GLPG0259 in healthy volunteers and sets us on course to initiate an extended trial in rheumatoid arthritis patients," said Onno van de Stolpe, CEO of Galapagos.  "We are very pleased with how this program is progressing and excited that we are on track to start the assessment of the first Galapagos-based candidate drug in patients later this year."

About Galapagos' R&D update and webcast presentation
Galapagos invites analysts, investors and journalists to attend an R&D update meeting in which an overview of the Company's clinical and pre-clinical pipeline progress will be given.  The meeting will take place at Galapagos' Paris research site, located at 102 Avenue Gaston Roussel 93230 Romainville, France, starting at 13.00 CET on 19 March 2010.

Galapagos management will present the R&D strategy, the latest information on Galapagos' discovery and development programs and an update to its clinical and pre-clinical portfolio.  Those who wish to attend the meeting in person should confirm their attendance via email to ir@glpg.com.

Galapagos will also hold a conference and live audio webcast of this meeting starting at 13.00 CET on 19 March 2010.  Click here to access the live audio webcast.  To participate in the conference call, please call +32 2290 1791 ten minutes prior to commencement.  A question and answer session will follow the presentation of the results.  The archived webcast also will be available for replay shortly after the live presentation.

About MAPKAPK5 and candidate drug GLPG0259
Target MAPKAPK5 is a new starting point for the treatment of rheumatoid arthritis (RA).  Galapagos discovered and validated the key role of this target in the RA disease process, using its proprietary target discovery technology.  MAPKAPK5 had not been previously associated with RA; however, Galapagos has shown that it plays a key role in inflammation and in the breakdown of collagen in human cartilage.  The candidate drug GLPG0259 inhibits MAPKAPK5 in human cells, and demonstrates excellent bone protection and reduced inflammation in a standard RA animal model.

GLPG0259 is a novel mechanism-of-action inhibitor of the protein kinase MAPKAPK5.  It is a compound in Galapagos' internal RA program, which is part of an option agreement with Janssen Pharmaceutica.  Upon the completion of a dose finding Phase II clinical trial for GLPG0259, Janssen has the exclusive option to license the program for 60 million, with further potential milestones to Galapagos of 776 million and up to double-digit royalties on global sales.

About Galapagos
Galapagos (Euronext: GLPG; OTC: GLPYY) is a mid-size biotechnology company specialized in the discovery and development of small molecule and antibody therapies with novel modes-of-action.  The Company is progressing one of the largest pipelines in biotech, with four clinical and over 40 small molecule discovery/pre-clinical programs.  Through risk/reward-sharing alliances with GlaxoSmithKline, Eli Lilly, Janssen Pharmaceutica, Merck & Co. and Roche, Galapagos is eligible to receive up to 3 billion in downstream milestones, plus royalties.  Together with the service operations of BioFocus and Argenta, Galapagos now has more than 640 employees and operates facilities in six countries, with global headquarters in Mechelen, Belgium.  More info at: www.glpg.com

CONTACT

Galapagos NV
Onno van de Stolpe, CEO
Tel: +31 6 2909 8028

Elizabeth Goodwin, Director Investor Relations
Tel: +31 6 2291 6240
ir@glpg.com

This release may contain forward-looking statements, including, without limitation, statements containing the words "believes," "anticipates," "expects," "intends," "plans," "seeks," "estimates," "may," "will," "could," "stands to," and "continues," as well as similar expressions. Such forward-looking statements may involve known and unknown risks, uncertainties and other factors which might cause the actual results, financial condition, performance or achievements of Galapagos, or industry results, to be materially different from any historic or future results, financial conditions, performance or achievements expressed or implied by such forward-looking statements. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. Galapagos expressly disclaims any obligation to update any such forward-looking statements in this document to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based, unless required by law or regulation.

Downloads

Title Download